Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:May 11, 2017
End Date:May 2020
Contact:Prajak Barde, MD
Email:pjb@rhizen.com
Phone:+41 32 580 0113

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A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas

A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or
Refractory Lymphomas

Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events
(SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT).

Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration
versus time curve (AUC), Time of Maximum Concentration Observed (Tmax).

Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS)
and duration of Response (DoR).

Inclusion Criteria:

- Refractory to or relapsed after at least 1 prior treatment line.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2

- Patients must be ≥18 years of age

- Able to give a written informed consent.

Exclusion Criteria:

- Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).

- Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune
deficiency virus (HIV) infection

- Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months.

- Patients with graft versus-host disease (GVHD)

- Subjects who have received drugs that directly or indirectly inhibit calcineurin or
Nuclear Factor of activated T cells (NFAT) activity .

- Patient with symptomatic, or history of documented congestive heart failure (NY Heart
Association functional classification III-IV);

- Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec;

- Patient with angina not well-controlled by medication;

- Women who are pregnant or lactating.
We found this trial at
7
sites
Salt Lake City, Utah 84106
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4100 John R
Detroit, Michigan 48201
800-527-6266
Phone: 734-325-3832
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Aurora, Colorado 80045
Phone: 720-848-0752
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Aurora, CO
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Benowa, Queensland
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Benowa,
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Birmingham, Alabama 35294
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Birmingham, AL
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Cleveland, Ohio 44012
Principal Investigator: Paolo Caimi, MD
Phone: 216-844-0139
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Cleveland, OH
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Duarte, California 91010
Principal Investigator: Alex Herrera, MD
Phone: 626-256-4673
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Duarte, CA
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